2012 Product Recalls
5,173 recalls issued in 2012.
Showing 5041–5060 of 5,173 recalls
MOTOR CONTROLLER/POSSIBLE FIRE
FAILURE OF THE MOTOR CONTROLLER CAN RESULT IN A FIRE.
GENIE WILL NOTIFY OWNERS AND DEALERS WILL REPAIR THE VEHICLES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 8, 2012. OWNERS MAY CONTACT GENIE'S SERVICE DEPARTMENT AT 1-800-536-1800.
HARNESS ADJUSTER DETACHMENT
SHOULD THE HARNESS ADJUSTER DETACH FROM THE SEAT, THE CHILD MAY NOT BE PROPERLY RESTRAINED IN THE EVENT OF A CRASH, INCREASING THE RISK OF INJURY OR DEATH.
BRITAX WILL NOTIFY OWNERS AND PROVIDE REPAIR KITS FREE OF CHARGE. THE SAFETY RECALL AND MAILING OF THE KITS BEGAN ON FEBRUARY 7, 2012. ANY SEATS ON WHICH THE HARNESS ADJUSTER HAS DETACHED WILL BE REPLACED. OWNERS MAY CONTACT BRITAX AT 1-888-427-4829 OR VISIT WWW.CHAPERONERECALL.COM.
Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2.
Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made.
Biokit USA notified US Customers by fax on 2/18/10 of the reason for the kit recall and requested to discard any remaining units. Accounts were advised to retest patients or review test results. Questions are directed to the firm at 800-926-3353.
GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK
Lack of sterility assurance due to compromised package seals.
The firm initiated their recall to their direct accounts by Priority Mail with delivery confirmation on 08/06/2010. The letter requested return of the product and was extended to the retail level.
LED Flashlight and Battery Set Recalled for Fire Hazard
The flashlights can heat up, smoke or melt when turned on, posing fire and burn hazards.
Consumers should immediately stop using all of the flashlights and return them to any BJ's Wholesale Club for a full refund. Consumers should properly dispose of the batteries before returning the flashlights to the store.
Utility Vehicle Recalled for Fire Hazard
An exposed portion of the exhaust system can allow debris such as leaves, brush or other flammable materials to enter the opening and ignite, posing a fire hazard.
Consumers should stop using these vehicles and return them to a KYMCO dealer for the free installation of a repair kit.
Synchron LX Systems Version 4.5 Operating Software
Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.
Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.
Cytomics FC500 with CXP Software
Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0
A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.
COULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)
BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.
Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.
Becton Dickinson issued an "Urgent: Field Safety Notice" beginning June 25, 2009 by telephone and letter fax to remove and discard affected product from their possession. Customer verification responses were requested. For further information, contact Becton Dickinson and Company at 1-781-906-7900.
Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.
The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition.
Abiomed notified customers via an Urgent - Voluntary Medical Device Field Removal Notice on May 8, 2009 advising users that the Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. The letter stated that customers may continue to support patients with the AB Portable Driver during the process since the failure has not occurred during patient support. An Abiomed Field Service Engineer will contact customers and arrange for a temporary exchange for the affected driver with a corrected driver. The firm recommends that customers switch the patient to hand pump support and switch patient to backup driver until they can confirm that the Driver(s) has been corrected by an Abiomed Field Service. Questions are to be directed to Michael O'Hara at 978-646-1543 or a Field Service at 800-554-8666.
Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.
ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.
ev3 Neurovascular sent a "NOTIFICATION OF RECALL" letter dated November 6, 2008 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop use and segregate the affected product from inventory. A reply form was attached to the letter for customers to complete and fax to Customer Service at (763)398-7001. Customer Service will issue an RGA number for the return of the affected product. Contact the Quality Systems Manager at (949) 680-1305 for questions regarding this notice.
R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507 This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-st
The specific lot was assembled without the rivet cover.
ConMed Corporation sent a Urgent Medical Device Recall Letter dated March 25, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately stop use of the device and return it to ConMed Corporation. Please review your inventory for any of the devices listed on Attachment I. If you do not have any devices to return, please follow the instructions in the letter and complete Attachment II, indicating you have no devices and fax it to 315-624-3225. Please complete the attached Business reply form. We apologize for any inconvenience this will cause you or your staff. For further questions please call (315) 797-8375.
Golf, service and utility vehicles Recalled for Crash Hazard
The lower steering yoke can loosen where it attaches to the steering rack and pinion, causing the driver to lose control of the vehicle and crash.
Consumers should contact local ParCar dealer for a free inspection and repair as required.
FMVSS 206/PRIMARY LATCH/DOOR CLOSURE WARNING SYS
Without either a primary door latch system or a door latch system with a fully latched position and a door closure warning system as required by FMVSS 206, the door could partially open without warning and the driver may not be aware that the door is not fully latched, putting the driver at an increased risk of injuries in the event of a crash.
Morgan Olson will notify owners, and dealers will repair the vehicles free of charge. The safety recall began on April 25, 2012. Owners may contact Morgan Olson at 1-269-659-0200.
***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain*** Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with
Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly.
BIOMET 3i sent an Urgent Medical Device Recall Letter on March 14, 2011, to all affected customers via emial or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told to contact Customer Service at 1-800-342-5454. Customers were instructed to respond with the attached Response Fax or email DomesticComplaints@Biomet.com. If customers still had implant(s) in their inventory, they were to return the implant(s) to BIOMET 3i using the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CD117886 A replacement implant(s) will be sent to them one the product is returned. For questions regarding this recall call 561-776-6906 (EST 8:00am to 5:00pm).
Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant (s), and
The device has the potential to not appropriately mate with the humeral stem.
DJO Surgical sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructed customers to quarantine affected products and to contact Customer Service to obtain replacement products and a RMA. Questions are directed to the Director of Commercial Logistics at 512-834-6330.
Oregon® Replacement Lawnmower Blades Recalled for Laceration Hazard
The replacement lawnmower blades can break during normal use, posing a laceration hazard to the user and bystanders.
Consumers should immediately stop using lawnmowers with the recalled blades and return the blades to the store where purchased or directly to Blount for a free replacement.
Bicycle Handlebars Recalled for Fall Hazard
The recalled bicycle handlebars can break while the user is riding the bike, resulting in loss of control and a fall hazard.
Consumers should immediately stop using the recalled handlebars and contact Euro Asia Imports to receive free replacement handlebars.
The Precision Implantable Pulse Generator, Model Number SC-1110
The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry.